Affinia Antiperspirant Deodorant Vanilla Musk and Jasmine

AFFINIA ANTIPERSPIRANT DEODORANT VANILLA MUSK AND JASMINE- aluminum zirconium trichlorohydrex gly stick
Melaleuca, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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AFFINIA ANTIPERSPIRANT DEODORANT VANILLA MUSK AND JASMINE
aluminum zirconium trichlorohydrex gly stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54473-338
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY (UNII: 8O386558JE) (ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY - UNII:8O386558JE)	ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY	16 g in 57 g

Ingredient Name	Strength
Inactive Ingredients
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETYL ALCOHOL (UNII: 936JST6JCN)
GOSSYPIUM HERBACEUM SEED RESIN (UNII: X408487D9E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
DIMETHICONE 100 (UNII: RO266O364U)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
C15-19 ALKANE (UNII: CI87N1IM01)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
BAMBUSA ARUNDINACEA STEM (UNII: NRA4497HC5)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54473-338-02	57 g in 1 APPLICATOR; Type 0: Not a Combination Product	04/12/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part350	04/12/2022

Labeler - Melaleuca, Inc. (139760102)

Registrant - Melaleuca, Inc. (139760102)

Name	Address	ID/FEI	Business Operations
Establishment
KDC/ONE Development Corporation, Inc		204006464	manufacture(54473-338)